Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 15681–15700 of 38,428 recalls
Recalled Item: Artis Q Biplane
The Issue: A software issue could potentially cause the stand
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee Biplane
The Issue: A software issue could potentially cause the stand
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly
The Issue: Vertebral hydraulic assemblies has incorrect expiration date printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly
The Issue: Vertebral hydraulic assemblies has incorrect expiration date printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated...
The Issue: Due to programming errors in the Controller, an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NUVASIVE MAGEC 2 Rod X.X mm XX mm
The Issue: Post-implantation separation of an actuator end cap component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnipod DASH Personal Diabetes Manager (PDM)
The Issue: In certain scenarios, the Omnipod DASH PDM may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) &
The Issue: Bilirubin assays may exhibit a positive bias with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for
The Issue: Bilirubin assays may exhibit a positive bias with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination
The Issue: Bilirubin assays may exhibit a positive bias with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114
The Issue: Bilirubin assays may exhibit a positive bias with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic
The Issue: Bilirubin assays may exhibit a positive bias with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the
The Issue: Bilirubin assays may exhibit a positive bias with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microbiologics QC SETS AND PANELS
The Issue: KWIKSTIK 2 Pack (REF 0778P) and QC Set
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P
The Issue: KWIKSTIK 2 Pack (REF 0778P) and QC Set
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific
The Issue: Boston Scientific released a new Software Update Application
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific
The Issue: Boston Scientific released a new Software Update Application
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nextra Hammertoe Correction System-4.5MM Middle
The Issue: Proximal end of the driver in the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexSite HD
The Issue: The action is to ensure consistency between the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NelDerm Hydrogel Dressing (Dressing: 6 x 6
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.